Description

Many of the dogs that are seen on a daily basis are present due to “ lumps and bumps”. The differential diagnoses for the mass include cysts, abscesses, scar tissue, and cancer, which can be benign or malignant. Diagnosis can be either an aspirate or biopsy. HT Vista is a new device that combines heat diffusion signatures with artificial intelligence. The rationale is based on the tissue's response to thermal excitation over a short period of time. The Algorithm compares the patient’s signal to learned signals and gives a probability of malignancy. The pilot study included 45 dogs with 69 tumors (28 malignant and 41 benign) and showed an accuracy of 88% and a negative predictive value of 92%. The validation study included 525 masses. 378 were designated as benign, 53 malignant, and 94 as non-diagnostic. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the system were 69%, 85%, 67%, 26%, and 97% respectively for all masses using the cytology and/or histopathology results as the gold standard. We propose that all lumps should be diagnosed and newer tools may help us make better clinical decisions.
 
Kindly sponsored by HT Vets.

Transcription

Good evening everybody and welcome to the webinar Vett and tonight's webinar is proudly brought to you by HTET. A huge big thank you to them for sponsoring tonight. If it wasn't for their kind sponsorship and their support, we wouldn't be able to bring these kinds of free webinars to you and share with you the amazing presentation that we have got for you tonight.
Little bit of housekeeping. My name is Bruce Stevenson, and I will be chairing the session tonight. If you do have any questions for our speaker, please just move your mouse over the screen.
You'll see a little control bar. It's normally a black bar at the bottom that pops up. There's a Q&A box there.
Just click on that, type in your questions, and we will be holding those over to the end, and then we will go through as many as we can. We are also recording tonight's session. So if there's something on a slide that you don't see, we can't go back to those slides, but you can go onto the webinar vet's website and go and watch again.
And when you watch it on demand, you can rewind and stop and pause it and as you wish. So, yeah. Remember, it's normally 24 to 48 hours.
It's back up on the webinar vet website. Tonight's speaker is Doctor Gillian Dank and she received her DVM degree from the Hebrew University in 1998. She completed her internship at the Core School of Veterinary Medicine, followed by residency in veterinary oncology at the University of California, Davis.
She's board certified both by the American College of Veterinary Internal Medicine, as well as the European College of Internal Medicine in oncology. Gillian was a senior lecturer at the Coret School of Veterinary Medicine until this year, when she decided to leave that work and go into private practise and has started to work with HD Wet as their chief veterinary officer. Doctor Dank has published and participated in studies evaluating novel diagnostics and treatment modalities for dogs and cats.
In addition, she has lectured to veterinarians all over Europe and Asia to Improve International. Gillian shares her home with her husband, Ronan, their 4 children, and their golden retriever. Gillian, welcome to the webinar, vet, and it's over to you.
Thank you so much. So I hope everybody enjoys my talk, and as, as Bruce said before, if you have any questions, please put them on the Q&A. I'd be happy to entertain any questions at the end of the talk.
So today we're gonna be discussing an overview of lumps and bumps, diagnostic approaches, the limitations of current diagnostics, bringing new techniques into your clinics, an overview of HTISA device, the evidence behind this new HTI. And the algorithm behind it, and how to integrate this device into your daily life in your daily clinic. So lumps and bumps.
So cancer is a worldwide leading cause of death in pets over the age of 10. Early detection is the most important step in cancer treatment and also has been shown to improve prognosis. Many of the dogs that you see on a daily basis present to you because of lumps and bumps, and these lumps and bumps can vary widely in their size and in their severity.
So some of the dogs that we see have pets with very astute owners, so they present with masses that they found yesterday, it might be just a few millimetres in size, and they already are causing their owners all sorts of stress. So here you can see two different examples of that. You can see on the left there's a dog that if you look, you could barely even see the mass, and the same with one with the dog on the right.
So it's just owners that are feeling and touching and palpating their dogs that they find these really, really small masses and they come in, and that's great for us as clinicians because the smaller they are, the better we can treat them. On the other hand, we can have dogs that have really large masses that have been there for weeks to months, as you can see in the pictures here. And I'm sure, as with my clinic, your clinics too, sometimes owners come in and say, oh, we just noticed this mass, it hasn't bothered the dog until now.
And as you can see in these pictures, obviously, the one on the right is quite a disaster, and it would have been much better if the dog could come in quite a while ago. So when we're getting a history when these owners come in, we have we have a few critical questions that we need to ask. One is, how long has the mass been there, if they even noticed it, when did they first notice it?
How much has it changed since you first saw it? Has the consistency. Has changed?
Has the size changed? Does the dog even know that it's there? Is it bothering him?
Is it itching? Is it causing lameness or pain? And are there any previous masses in the history that were surgically removed before this mass appeared?
So all of these questions are really critical for us to have the full picture about what's going on because clearly if a mass appeared in the last week, and it's the size of a baseball, it's going to be different than a mass that's been there for months and months. If a mass is causing pain, it also can have different differentials than a mass that isn't bothering the dog at all. So it's really important to have a really good history with these specific questions about masses.
Obviously, anytime you're doing, your dog comes in or cat comes in, you need to do a full physical exam. But the critical points on the physical exam that we want to ask about and look at for a dog with a mass are the measurements. So hopefully, most of you in your clinics have callipers, so you can measure in centimetres the size of any mass that you have.
It is really, really important to Measure them, first of all, because not all of you are the only ones that work in your clinics, and if you don't know the size when they come in the first time, they won't be able to compare it the second time. So anybody who doesn't have a calliper or a ruler, it is really, really recommended. We also want to report in the in your files the location, where it is on the body.
Is it dermal, is it subcutaneous? Is there any hair on the mass? Is it firm?
Is it soft? Is it well defined and circumscribed, or is it edematous where you really can't know where it starts and It ends, and obviously if the mass is ulcerated. So we want to to report all of these things in our medical records, so we know what we're looking at, and so doctors in the future, or you, if you kind of forget because you've seen so many cases, know what you saw on that first visit.
In addition, on the physical exam, we want to look, are there additional masses and what's going on with those local lymph nodes? Is the local lymph node is enlarged? Is it firm?
It's really important to look for them. So I just wanted to start with a say as an example of a dog. Her name was Mika, a 10 year old female Maltese, and she presented with several masses on her right front leg in the axe and the axi layer region.
So here you can see her masses and you can see in one of my many callipers that I have in my office. And so you can see here, there was one mass on the right front leg. Here it was on the other on the caudal aspect and then another one in the axillary region.
So obviously any mass that comes in, we measure and map and write everything in the medical records. So obviously any mass that we see has multiple differentials, and we need to, we will discuss that in a second, but just so you see why you want to continue to listen to this webinar and why you're listening to me instead of doing other things, is that the reason we're talking about this is because of the HTV device. And so we actually checked these masses, Mika masses with the device and what You can see is this is the readout that we will receive and we'll be talking about on the continuation of this talk.
Here's Mika's name, here's the report, and what we can see is this is the mass and it received a one. And the meaning of the one is that this requires further investigation. And so we can't just send her home and think she's going to be OK.
Something is alarming and needs to be dealt with. So HD Vista is the first non-invasive medical device that allows veterinarians to rule out cancer on the spot in the clinic. So in Mika's case, we most likely ruled in cancer, but in many cases, we can rule out cancer and then send them home happily.
So after we have a history and a physical exam, obviously we want to do a problem list and a list of differentials. So differentials for different masses that we see on dogs and cats on a daily basis include cysts which can which can be either sebaceous or fluid-filled. Abscesses, scar tissue, and obviously cancer.
And any cancer that we see can either be benign or malignant. And obviously, sometimes we can rule out some of these causes based on the history. So if a dog doesn't have a history of trauma or previous surgery, then the chances of being scar tissue are much smaller.
So what do we want to do now with the mass? There are a couple of options. We can aspirate it, we can biopsy it, or we can just do nothing and send the owner home and say, let's watch it and come back.
So we do not agree as, obviously, I do not agree, as a veterinary oncologist and other, no other veterinary oncologist thinks so, think that we should just watch it, OK? So anytime that we have a mass, we have an owner coming in with because of a mass or we find one, we think that we should be proactive. And we can never know whether a mass is benign or malignant by just looking.
So it would be nice if we could all be Superman, but obviously we are not, so we want to do something about these masses and not just send them home. So what are the advantages and disadvantages of fine needle aspirates? So the advantages are that they are minimally invasive, low risk, don't require anaesthesia and have fast results.
However, there are some disadvantages. They can cause some mild patient discomfort, and 20% of the cytology samples are non-diagnostic, and the negative predictive value, which means that if the test comes out as negative, what is the chance that it's actually negative is 70%. Diagnosis is also delayed if the samples are sent to an external laboratory, and that can increase the cost for the owners.
So besides finding aspirin, obviously, we have the option of doing a biopsy, which is the gold standard for definitive diagnosis, and the results determine the optimal treatment plan. However, it does require anaesthesia, usually general anaesthesia. In order to do it.
And obviously, the dog or cat has to recover and they can need, after the surgery, they can sometimes need an e-collar or medications, and obviously it's much, much more expensive because of both the anaesthesia, the procedure, and the histopathology afterwards. So the facts that can factors that can affect our ability to diagnose is the location of the mass. Is it easy to get to?
Does it require sedation to either do an aspirid or a biopsy? The dog, will he even let us do it? Obviously in cats, at least in Israel where I live, cats are very difficult to deal with if they're not asleep.
And then of course the owners. What are the costs? Do they have a fear of tests, a fear of sedation, anaesthesia, and what is it really going to change what we're going to do, which is a key point in veterinary oncology, because any test that we do, we want to rationalise it that it's going to change the next step, because otherwise there's really no point in doing it.
So, as I said, we need to rationalise these tests. What are they going to how are they gonna change what we do next? And in most cases it will change.
For example, knowing what kind of tumour we have will change the staging, will change the staging test that we choose to do, because they're all based on the tumour types, and it will also change the type of surgery we recommend because the aggressiveness of the surgery is based on the tumour type. So what are fine needle aspirates? So I'm just gonna go over this quickly because I'm sure that you all do them on a daily basis, but there are two different ways to do fine needle aspirates.
The one is without aspiration, so we just take a needle and jab it into the tumour, take it out, and then smear it on the slide. This uses a much smaller needle, either a 25 or 27 gauge, and there's no aspiration actually happening. And the huge advantage of this is that it's a small needle, and minimising minimalizes bleeding, and so you get a much cleaner sample.
Aspirating with a pullback on the syringe is also an option, but usually, usually it's more cellular but has more blood on it. So after we aspirate, we apply them to the glass slides, pull apart, and then have a good monolayer of cells that we air dry and then stain. If you happen to have thin plastics on in your clinic that usually are used for your analysis, it's much better to use them for that top layer, and then you get a better slide because they're much thinner, and they they smear out the slides more evenly and do less damage to the cells.
So complications from finding aspirates are quite rare. There is, there are reports of seeding along the biopsy tract, much more in people than in animals, could cause haemorrhage, infection, and if we're aspirating masses in the lungs, potentially it could cause pneumothorax. So it's not a reason not to do a fine needle aspirate, but it is a reason to talk to the owners about possible complications before you do them, so you don't have problems.
Obviously afterwards, do we do the aspirate, we want to stain them and try to stain one of those smears before you send it to the lab to make sure you're submitting a cellular sample. So when we're looking at the cellularity, we want to see is it cellular or not. If it isn't, then it really is not worth sending it to the lab because they won't see anything either.
So try to resample. If you only have red blood cells, resample cause they're not gonna see anything else. If you have inflammation, you really think it's a tumour.
Resample. And if all the cells are ruptured, they won't give you a good answer either. If there's a great deal of inflammation, the inflammation can change the epithelium mesenchymal cells that you're looking at to make them look atypical, and that can give you a false positive response.
So obviously it's important to know to look first what you're looking at. Is it a good sample? And only if it's a good sample, send it in.
Otherwise you're wasting your time and your money. When we're sending it in, we want to send in unstained slides in addition to the slides that you looked at and stained, if possible, because the stains that they use at the external labs are better usually than most people have in their clinics, and they can stain the granules and mast cell tumours more consistently. About 20% of the granules and and mast cell tumours do not stain with this quick.
So when we're looking at cytology, we want to see is the sample cellular? Cellular means nucleated cells and not red blood cells. Is it normal tissue?
Is it inflammatory, and is it neoplasia. If it's neoplasia, we only split neoplasia into three different groups, epithelial, mesenchymal, or round cells. And then after looking at that smear, we want to try to understand, is it benign or is it malignant.
So if we think it's inflammation and not cancer, obviously that's a great thing, and then we want to try to look at what kind of cells do we see? Are there neutrophils, macrophages, einophils, lymphocytes, plasma cells, mast cells, and do we see the reason for that inflammation, the ideological agents such as bacteria or fungi. But if there's a mass with no indication of inflammation or a reason for that mass, then it is most likely neoplasia, and that neoplasia could either be benign or malignant.
So the criteria of malignancy when we're looking at cytology smears is our large number of irregularly shaped and dividing cells. Anosoaryosis, high NC ratios, anisocytosis, anaplasia, and, and now we can see some real pictures of those. So these pictures are cytology smears of mitotic figures over here.
So here you can see mitotic figures in a dog with lymphoma and a beautiful mitotic figure of a cat with histiocytic sarcoma. On the bottom left, you can see irregular nuclear shape, anisoaryosis in the dog with a mesothelioma, and on the right you can see it in that same thing in a cat with a histiocytic sarcoma. In this slide, we can see on the left, multinucleated cells, so it's a huge cell in a dog with an adenocarcinoma.
In the middle we can see cytoplasm with many, many vacuoles. Again, these are all signs of malignancy. And then on the right we can see increased NC ratios.
So all of these cells, whenever we see them on cytology, mean that the, in this case it is a carcinoma and not some kind of adenoma. So if we find neoplasia, what type is it? So again, we only have 3 types in in our in our clinics, we have epithelial, mesenchymal, and round cell tumours, which makes it really easy to understand because they all look very different.
The epithelial tumours include glandular or parenchymal tissues, the mesenchymal, connective tissues, muscle tissues, bones, and then we have the round cells. So epithelial tissues, the nucleus is usually round to oval, as you can see in this in this example, on the side. Clusters, they come out as clusters or sheets, and they're round to polygonal.
The cytoplasmic borders are often indistinct because the cells are adhesed to each other because of the tight junctions. So when we aspirate instead of coming out as all sorts of different cells, they are stuck together because of the tight junctions, and that's why they come out in those clusters that we see and that we see here. So they exfoliate very well in fine needle aspirates, and they are obviously called either adenoma if they're benign, and carcinoma if they're malignant.
So the most common carcinomas that we see in cats are squamous cell carcinoma and basal cell carcinomas, and in dogs, sebaceous adenomas and adenocarcinomas. And usually, if we can, the best treatment for these dogs and cats is surgery. Obviously, if they're not surgically resectable, we have other options, but if we can, we wanna try to cut them out.
The next group are the mesenchymal tissues the mesenchymal tumours. The nucleus is usually oval or elliptical. They exfoliate individually and occasionally in clumps, but usually individually.
The cell shape is spindle or comet shaped, as you can see here. And many have stroma in the background, and often they don't exfoliate well and aspirate or even are acellular. So the names for these tumours, as I'm sure everybody knows, are either benign, ending in Oma like a fibroma, or if they're malignant, it's sarcoma like a fibrosarcoma.
And biologically, the sarcomas are split into two groups. They are the typical sarcomas and the atypical sarcomas. So the typical sarcomas are soft tissue sarcomas, so they're slow growing, and usually you kind of kind of look at them as if they're an octopus or a tree root.
So on the top we have our tumour, and on the bottom we have our roots. And the majority only require local control, but local control means removing the tumour and all of the roots, and the grade matters, so they're actually split into grades 12, and 3. Most will grow back after surgery with dirty margins, and common types include nerve sheet tumour, manges pericytoma, and fibrosarcoma.
The atypical sarcomas include osteosarcoma and hemangiosarcoma, and they're locally aggressive and systemically aggressive. So then you need to stage them before surgery to make sure there's no evidence of metastasis at the time of diagnosis. Evidence that mastasis.
That we see. We know biologically that there is micrometastasis at the time of diagnosis and that's why in the end, they all metastasize. After surgery, adjuvant chemotherapy is recommended because of those micrometastasis and will double the survival times.
So melanoma is kind of a weird tumour, and because it can appear round ovoids, spindoloid, and it can bear as single and clusters, so it's very difficult to diagnose if we don't see the pigment, and some people put them in the round cell category, and some people put them in the spindly category. So it's kind of depends on which article you read. Obviously, biologically, the cutaneous are much less aggressive and the oral and the digit are more aggressive, and here you can see the pigment.
So now we're back to the round cell tumours, which are the best tumours to try to diagnose on cytology, because they're very different from one from one from another. The nucleus is round and indented, and the individual cells are also very round, and their cytoplasmic borders are distinct, so you can actually look and see cell by cell by cell. As in this sample.
Sometimes if the prep is very thick, they can look piled up one and another and then it's harder to diagnose, and they exfoliate very well with fine needle aspirates. So we only have 5 types of round cell tumours, which also makes life much much easier. We have the lymphomas, and obviously lymphoma is a systemic disease that requires systemic treatment.
The mast cell tumours, which are mostly surgical and require local control, obviously higher grades, bad locations, bad prognostic indicators may require additional chemotherapy and or radiation therapy. We have the TVVTs which are most mostly cured with vincristine. The histiocytic tumours, which are a wide variety of tumours based on their biological activity, from the benign histiocytomas in young dogs that cure by themselves to histiocytic sarcomas that are local and disseminated his sarcomas which require systemic treatment.
And the last of the plasma cells, which could either be multiple myeloma which requires systemic control, or plasma cell tumours that are treated surgically. So now for some pictures. So on the left we have a picture of lymphoma.
You can see large cells with cytoplasmic basophia that can either have vacuoles or not, and dispersed nuclear chromatin and nucleoli with a very high NC ratio. You can see the nucleoli. And on this side, we have a typical TVVT which again round cells with distinct cell borders and often have vaculated cytoplasmin, which many people call a string of pearls around the nucleus.
Here we have a plasma cell tumour, which have ovoid cells with basophilic cytoplasmin with an eccent eccentrically placed nucleus, and a very distinct Golgi zone, which you can see over here, which is very light in colour. And then obviously on the side, we have mast cell tumours which have their granules and that are very characteristic, which can depending on the the way that you did stains work, can either be more red or more purple. So the limitations of cytology include the quality of the smears, the cellularity of the sample, and the lack of tissue architecture, and obviously we can also miss geographically with the needle.
So wouldn't it be amazing if we could know if the lump is benign without doing aspirates and biopsies with a noninvasive approach? That way, if we know the mass is benign, we could confidently wait and see. If we think it's suspicious, we can recommend and rationalise the need to work up the case with either an aspirate or a biopsy.
So what would we want as clinicians, we would obviously want a good screening test. So what's a screening test? A screening test is done to detect potential health disorders or disease, and the goal is early detection to reduce the risk of disease or detect it early enough to treat it most effectively.
And a classic example in veterinary medicine is the Cushing's syndrome screening test. So as clinicians, what we require in a good screening test is obviously a high negative predictive value. So a high negative predictive value means that benign is benign.
And obviously as clinicians, the last thing we want to do is send home a dog with a malignant tumour when we think it's benign. So we need benign to be benign, which means a very high negative predictive value, and we also want a high sensitivity to detect those malignant tumours. So again, we do not want to send home a patient with cancer.
So what's new to help us decide? Combining heat diffusion signals with artificial intelligence. So this is a new tool for veterinarians to assist in screening and decision making.
Do I need to ask for it? Do I need to biopsy, or can I watch and wait safely? So artificial intelligence in veterinary medicine is is becoming the the in thing to do.
So the input is what we measure, and the algorithm is what the computer has learned from previous cases, and the output is what we can choose to act on, and the algorithm is the key. So these are distributors at this point, just so you see that it's not something I'm making up. This is something that is already worldwide and amazing, so you can see that it is all over the world, including the US, Holland, Spain, Israel, and all the way to Australia.
And they're even going to be at the London vet show, so if there are people here that are gonna be in the London vet show, please go on buy at booth Q10. You can also see here already, this is the HTV device. It comes as an iPad, and here is the device itself that you hold, the handheld device.
So the physiological rationale behind this technology is based on the tissue's response to thermal excitation. Over a short period of time, so healthy and malignant tissues have different physical characteristics, and the thermal diffusivity in living tissues is based on the density, the thermal conductivity, the metabolism, the vascular network, and the heat capacity. So this is a really exciting part to us as veterinarians understanding why it works and why it's so interesting.
So what happens when we heat up tissue is here you can see down here the heat source is turned on and The tissue heats up. So here it's heating up to a little bit below 41 degrees, and then over time it cools down. So that's easy to understand and everybody looks in that, and that's OK.
But the fascinating part is that if we heat up healthy cells and cancer cells, that sometimes they heat up to the same degree, sometimes not, but they cool down differently. So the lead heats the tissue, and then the device records how they cool down. And then we can see the differences between the healthy cells and the cancer cells.
So it looks simple, it really is not as simple as that, but at least now from this picture you can understand the rationale. So here are a couple of examples for you to see the complexity and how fascinating it is. So this is a low grade masal tumour that you can see up here.
This is just a picture of the tumour, and these are the thermal images. So what you can see, this is at the beginning and this is after heating, and here in this in this example, you can see that thermal images don't have differences. They're very similar between the healthy and malignant tissues.
So this is, sorry, so these are, this is the healthy and malignant, the signs. But the graph over here shows that there's that the malignant tissue cooled down much faster than the healthy tissue. So here we have the healthy, and here we have the mass, and you can see the difference in the way that they cool down and then the rate that they cool down.
So just looking at the thermal images is not enough. They need to combine looking at the thermal images and the signals. The secon example is a lipoma.
So here again, the thermal images don't show a difference between the healthy and malignant tissue, but the graph shows that the lipoma did not heat up as much. So you can see here this is the mass and this is the healthy tissue. So we have the mass heating up less than the healthy tissue and cool, but they cooled down in a similar fashion.
So here you can see that the grafts are very similar. And here yet another example of the basi basal cell tumour. So here you can see the tumour over here.
And the heating up over time. And you can see that there is a difference between the healthy and benign tissue. The tumour is red and didn't heat up as much as the healthy tissue.
So the tumour is heating up less than the healthy tissue, and the graph graph shows that the basal cell tumour and the healthy tissue elevated to different temperatures and didn't heat up in a similar manner. So here you can see that this, that the healthy tissue is all the way up to about 43.5, 44.
The tumour is heating up only to like 41, and they're cooling down differently. So different tumours respond differently in the thermal images and in the cooling down phases. So what happens when we scan these tumours?
What is the process? So it takes about 2 minutes after you get used to it and you know how to use the device. First you have to identify the mass and clip the fur, then you scan it, and the heat waves are sent to the tissue.
The thermal sensors measure the heat diffusion signal. You mark the area of concern and the healthy tissue, and you upload it, upload it to the cloud, and then the results returns are returned on the spot and you receive this report. So exactly the same way that we saw it at the very beginning in Mika's case, you receive a report with orange and green numbers.
So if it's orange, further investigation is recommended, and if it's green, the mass appears to be benign. So so far we've done two studies to try to understand this this algorithm, and to do it to see whether it works in differentiating between benign and malignant masses. Again, this is for primary clinicians in the clinics.
So what results do we have so far? So the pilot veterinary trial was a prospective clinical trial. And 45 dogs that presented to me at the veterinary teaching hospitals at Hebrew University with external masses, and any dog that had an external an external turmoil that could be pal palpated and measured and had a definitive diagnosis could be included, and they had either cytology or biopsies performed.
So we had 45 dogs with 69 different masses, and 27 were malignant, and 42 were benign. So these are the benign lesions. I'm not gonna read them through all of them, but you can see that there's a wide list of different kind of tumours.
And these are malignant lesions, again, many different kinds of tumours, lymphomas, mast cell tumours, carcinomas, and sarcomas, basically a wide range of everything. And results of this study showed that the accuracy was 90%, and the most important number is the negative predictive value, which was 95%. So again, negative predictive value, the higher it is, it means that we're not sending home dogs with cancer, and you can see that in this confusion matrix down here.
So the true positives were 25 dogs, there were 2 false negatives, 5 false positives, and 37 true negatives. So why did these dogs, which were which tumours did the false negatives and false positive have? So 7 of the 69 were misclassified.
The false positives were 1 carrot and cyst, 3 lipomas, and 1 sebaceous gland adenoma. Apparently some of the lipomas because they were too deep for the for the device, and the 2 lesions that were called that were false negatives were 2 lymphomas. Sorry.
So from that, we went on to a training study. So this was a training cohort, including the diagnosis and thermal signals signals produced. So what we, what a training study is that it takes a lot of different dogs with a lot of different.
That have definitive diagnosis, and they take all of this information into the algorithm to choose features that are appropriate, and then make a fixed algorithm so that afterwards we can do an additional study with a fixed algorithm. So this algorithm was trained in 147 dogs with 233 masses. And it resulted in an algorithm with 3 different features.
So that led to the validation study. So the validation study was a prospective validation study held in from last November to July at different veterinary clinics in Israel, and 525 masses were scanned with the HTISA, and they were either aspirated or biopsied, and all of the aspirates and biopsies were sent to external laboratories for diagnosis. So these dogs came on specific days to be scanned and they received the answers.
On site at the clinics. So, of all of those dogs, cytology was non-diagnostic in 94 masses. So obviously that resulted in 431 masses from 248 dogs with diagnostic samples.
The study included a wide range of benign and malignant tumours, and we had 53 malignant lesions and 378. Benign lesions. So these different numbers are a little different than the pilot study because the pilot study had more malignant lesions because it was performed in a specialty clinic, and this was this study was performed in regular clinics all over the country, so this is much more similar to private clinics.
So what were the diagnosis? So here you can see the ones which were diagnosed on histology and which were diagnosed on on cytology and histopathology, and these were the benign and these were malignant. So the benign had a wide range of lipomas and epithelial tumours, and malignant we had carcinomas, masal tumours, and soft tissue sarcomas.
So what about the predictions with the device compared to the the diagnosis either on cytology or histopathology, and what you can see here is the benign and the malignant. And benign and malignant. So what did the machine call it?
What did they think and what what was it really? So here we have benigns were called benigns in 253 cases, benigns were called malignant in 125 cases for a total of 378 dogs with with benign tumours. For the malignant cases, all of the carcinomas and sarcomas were called malignant, and there were several mast cell tumours that were called benign.
So here you can see this in the confusion matrix, as I said before, we had 8 false false negatives, all low grade mass cell tumours, and then many more false positives. So that leads us to the evidence. So up until now, the TIA has been tested on over 1000 dogs, leading us to a negative predictive value of 98%, which means that in 98% of the cases that the device says it is benign, it is benign, which gives us the confidence in saying that we are ruling out cancer.
So how do we think this should be used in your private clinics? Any dog that comes in with any kind of mass should be scanned with the HT VISTA device, and then we get a result. If you get a result of 5 to 10, then the mass appears to be benign, and there's no need for further diagnostics, and there's a probability of 98% that this mass is benign, which is pretty much as good as it gets in a scanning test.
If the result is a 1 to 4, then further investigation is recommended, and we recommend to do a finding last for it if possible. If it's malignant, obviously we need to treat and stage according to the diagnosis, and if it's benign, follow-up is based on the clinical judgement. If it's Non-diagnostic, obviously, you have to continue the workup.
So clearly there will be cases that they receive a further investigation recommended when they are benign, but obviously as a screening test, it's much better to have those than to have cases that we're sending home with cancer. So here's another case study of a dog, a beagle named Stella. She's a 10-year-old beagle, and the owner's noticed several lumps.
One of them was itching. On physical exam, she had 3 subcu lumps on the right thorax and the right axilla. So these are her three lumps, and 2 of them were diagnosed as lipomas, and here you can see that they both received a 10, which means they're benign, but one of them wasn't.
So one of them received a 3. So this all three were aspirated and this turned out as a mass cell tumour. So I'm sure as you know, that some of these older dogs come in with lumps and bone.
And one's a lipoma, 2 is a lipoma, but certainly not all of them are necessarily mast cell tumours. And the same goes in the opposite direction. The fact that the dog has 1 mast cell tumour and they have 5 lumps doesn't mean that they're all mast cell tumours.
So we need to understand every single lump. Is it benign or does it warrant further diagnostics? So the benefits of this device are I'm sure are clear to you now.
For the owner and the dog, it's a low-cost screening tool, pain-free with no needles. It relieves stress from the owner and can be used for screening, even for multiple masses. And for the veterinarian, you get fast results.
The scan, after understanding how to use it, takes about 1 minute and the results back within 2 minutes. It generates more diagnostic procedures. For your clinic and rationalises the need for further diagnostics, which leads to improved compliance.
It replaces the wait and see, and the clinic is perceived by customers as advanced with cutting edge technology, and the high negative predictive value gives you the confidence that a mass is benign with a medine result is benign, which is what is most important. So what does this tell us? We don't want to miss tumours, and we have a 97 to 98 predictive value, which is excellent and benign is benign.
Obviously, this is not replacing the Bearian, it is a screening tool that is trying to find suspicious lesions that may include malignant, inflammatory, infectious, and even some benign lesions, but it helps us to decide which lesions we need to evaluate further, and this can increase the client willingness to pursue diagnostics. So, I would be happy to entertain any questions. Gillian, that was a fascinating insight to this new technology.
So a big thank you to you for your time tonight and also a huge thank you to HDET for sponsoring this evening's session. We do have an interesting question that's come in. Does the device distinguish between inflammation and neoplasia, or inflammation and neoplasia with inflammation?
And should one attempt to reduce the inflammation before assessing the mass? So that's an excellent question. In some cases, inflammation can cause it to be positive and then, and thus requiring further diagnostics, so it's not necessary to give antibiotics before diagnosing.
OK. But would you put them onto a, a, a short course of NSAIDs or something like that for a few days? No, not usually.
I think it's more important to diagnose it and to deal with it. Because if there's inflammation secondary to a tumour, then it probably won't help. OK.
A couple of questions coming through obviously about cost factors for this. So I am not in marketing, but if anybody has any questions, then you can forward them to me and I can have people get back to you. Fantastic.
Good idea. Claire asks, is there a minimum size of the mass, that can be used? No, not really.
I mean you can get pretty small, and, and that's not an issue, and if you have really large masses, then the important thing is to have both healthy and, and the mass, so then you just do it at the margin. OK. So even if the mass is too big to fit into the the the system, you can still read just part of it.
Yeah. OK, that's, that's really very, very handy. And the other thing now, is this equipment available now or is it still this part of the launch?
It is available in many different places all over the world, and I'm sure that it will be available very soon. If you come to the vet show, then they can give you all that information. OK, yeah, that's always good.
Yeah, and contact the company or send yourself an email. And of course, the wonderful Dawn at the webinar vet is going to have those details if, if anybody needs to send in an email and, you're not sure where to send it, send it to Dawn, and, she can always forward it through to Gillian. Elizabeth wants to know, does this work with masses on deeper structures, such as on bone?
So we did have one osteosarcoma, and it works, but it really depends on the depth. So one of the future directions that we're going to do is deeper tumours, but there is a depth of about 0.5 centimetre and it beyond that, if you have normal tissue, and then the tumour is much deeper at this point, it's not gonna get that deep.
OK. But if you have an osteosarcoma on a dog that's that's quite superficial, then it will. Excellent, excellent.
Tommy, Tommy is asking, as the decision-making process is a yes or no type system, what is the reason for grading the masses 1 to 4 and 5 to 10? At some, if as masses as the as the grade decreases from a 4 to a 1, the chances of malignancy increase. So it's it, so if you receive something that's really borderline, then it's more of a borderline case.
So it's it's more than just a yes, no, it's a, it's a scale. It's a shades of grey. Exactly.
We don't like to have just yes and no inventor. Especially not in oncology and mass masses have never heard of yes or no. I'm not sure this is going to, to, not require a whole new webinar on it, but, Charlotte asked, can you touch on the significance of information on the in-house slides?
How do you know that you've got inflammation, that is due to neoplasia or another process? I think it really matters on your physical exam and what you see and your history, to understand whether, so, so if you have a mass that's really large, you know, something mass like, and you have inflammation, and you get an aspir of inflammation that it's probably secondary to a mass, but if you have something much flatter or some kind of history, then it's more of a chance of just being inflammation. But I think it's really a clinical question that you have to go on a case by case decision.
So it's, yeah, it's the basis of, of suspicion based on clinical and then your, your aspirrates and that are more of a, of a confirmation or a, a decision making tool very much like this process with the, the scan. Exactly. Vladimir wants to know, is, was this tested only on dogs, or does it work on other species at cats as well?
So, so far, everything that we've done has been on dogs, and the next trial that we're going to do is gonna start on cats because I know everybody wants to try on cats too. It's just that we, we, we do think it's going to acquire a completely different algorithm because of their skin is different. So, so so far we've put in all of our efforts into dogs and we're gonna start cats really quickly.
OK. Yeah, I, I mean, obviously, the, the, the, idea behind it to help with other species is fantastic. But, we all know that cats are not small dogs that climb trees.
So, yeah, it's gonna take a bit more work. a great question that's, come from Lars, and I, I think it ties into, to general veterinary medicine, not just into the, into the scanning process here. But, could you elaborate on how you would handle those false negative tumours where you may be sent the animal home, believing it's benign?
I think this this probably goes in and correct me if I'm wrong, but goes into explaining before you even get started. And that goes for FNAs, biopsies, anything like that. It's about setting expectations for the owners and and explaining it to them.
Exactly. So, so obviously it would be really nice if there were any kind of tests in veterinary medicine that had 100%. And the more we read, we understand, as you could see in the in the in the results that I showed, the fine needle aspirates are not 100% either and not even close.
So 98% is, is excellent, and I, and, and especially considering that the ones that we had that were were incorrect were low grade mass cell tumours. But I think that you have to discuss it with the owners, and obviously, you know, if there was something in one of those cases that kind of said to you as a clinician. I'm not really OK with this.
I think this might not be OK, then I would ask the owners to come back in, but I think that, you know, any test that we can have it in 98% negative predictive value is as good as it's gonna get. Yeah. Yeah.
And I, I think that's important. The scan is not a, a foolproof be-all and end-all. You no longer have to examine the animal and just scan the lump, and it'll give you an answer.
It's part of everything else. You know, it's like a blood test or a, or, an X-ray or anything else. It, it's part of your diagnostic makeup, rather than a, a be all and end all.
Hannah asks a really interesting question. Is this technology being used in humans? So that's another webinar completely, but yes, the, the, there was one, study done in humans even before I started doing this, the studies in dogs in oral tumours, they got unbelievable results, and now they're looking at all sorts of other things in humans, involving in margins in intraabdominal surgery and all sorts of stuff like that.
So yes. Excellent. So that's very exciting.
Very, yes. Excellent. We've had a lot of comments coming through about a fantastic presentation, and, how fascinating this is and, and the potentials that, that it does hold for us.
One more cat is sent through. If you get a high number, how frequently would you suggest rechecking? If it's benign.
Yep. I, I don't think you have to worry about it unless there was something clinically that didn't look like it fit. I think you can just send the dog home and say, this is benign, see you for your next yearly geriatric workup or whatever it is.
Yeah. So it then becomes, rather than a, a risk of malignancy, it rather becomes a, a, a space-occupying lesion. You know, like that one on the front leg that you showed.
If it's in the axilla and it's growing, it may be worth removing before it starts causing physical obstructive problems, rather than because it's a, a neoplastic problem. Exactly. Constantinos asks an interesting question.
Does this work on mammary gland tumours? OK, so that's an excellent question. So I, I think, first of all, we have not checked it on many mammary tumours because fortunately in Israel, many dogs are spayed, so we just don't see that many.
And the reason as an oncologist that I don't think that this should be used in mammary tumours is because, as I'm sure you know, mammary tumours are one of the only tumours that have been shown to switch from benign to malignant. So if you have a dog, that you even knew it was a benign tumour, there would still be a clinical reason to remove that tumour. So even if you did this, unless, you know, it was a really old dog that you probably weren't gonna do surgery on anyway, there is a reason oncologically to remove that tumour in any case, and that's why I don't think it's critical.
Yeah, the mammary tumour is the great pretender, isn't it? Yes. Likes to pretend it's one thing and then bites you and it turns into something else.
Right, lots and lots of great comments coming through and thanks to you, even all the way from Lithuania. Thanks, Lena. And lots of comments coming through about how people are very keen to get their hands on the device and start.
Using it. So I think we can say that this has been a fantastic and successful presentation, Gillian. Thank you once again for your time tonight.
And a big thank you as well to HTET for their sponsorship of this evening. Thank you very much. To all of you for attending tonight, thank you for your time and I hope you've enjoyed the presentation and that it has stimulated some thought processes at least.
If you have got any questions, that we haven't covered or if you want to know more about the device, drop an email through to Dawn, and she can forward it through to Gillian and the team at HGET. And, As always, to Dawn, my controller in the background, thank you for making things run smoothly. From myself, Bruce Stevenson, it's good night.
Thank you, Bruce and Dawn. Bye everyone.

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